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Last Updated: May 21, 2022

Loxapine - Generic Drug Details


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What are the generic drug sources for loxapine and what is the scope of patent protection?

Loxapine is the generic ingredient in five branded drugs marketed by Alexza Pharms, Teva Branded Pharm, Actavis Labs Ut Inc, Elite Labs Inc, Lannett Co Inc, Rising, and Watson Labs, and is included in eleven NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Loxapine has two hundred and twenty-seven patent family members in twenty-one countries.

There are eight drug master file entries for loxapine.

Drug Prices for loxapine

See drug prices for loxapine

Recent Clinical Trials for loxapine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Lariboisière-Saint Louis clinical research unitPhase 3
Assistance Publique - Hôpitaux de ParisPhase 3
Lee's Pharmaceutical LimitedPhase 3

See all loxapine clinical trials

Medical Subject Heading (MeSH) Categories for loxapine
Anatomical Therapeutic Chemical (ATC) Classes for loxapine

US Patents and Regulatory Information for loxapine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Branded Pharm LOXITANE loxapine succinate TABLET;ORAL 017525-006 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Branded Pharm LOXITANE loxapine succinate CAPSULE;ORAL 017525-002 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Lannett Co Inc LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 090695-001 Sep 26, 2011 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for loxapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 See Plans and Pricing See Plans and Pricing
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 See Plans and Pricing See Plans and Pricing
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 See Plans and Pricing See Plans and Pricing
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for loxapine

Country Patent Number Title Estimated Expiration
European Patent Office 2096374 Unité de chauffage autonome et unité d'administration d'un médicament utilisant une telle unité de chauffage (Self-contained heating unit and drug-supply unit employing same) See Plans and Pricing
Czech Republic 20033249 Způsob tvorby aerosolu pro inhalaci (Method of making aerosols for inhaling) See Plans and Pricing
World Intellectual Property Organization (WIPO) 03041693 See Plans and Pricing
Australia 2003295823 TREATMENT OF HEADACHE WITH ANTIPSYCHOTICS DELIVERED BY INHALATION See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for loxapine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1389098 CR 2013 00046 Denmark See Plans and Pricing PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
1389098 C300609 Netherlands See Plans and Pricing PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098 1390040-2 Sweden See Plans and Pricing PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001 20130220
1389098 2013C/054 Belgium See Plans and Pricing PRODUCT NAME: LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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